[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lumbar-spinal-stenosis-lss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lumbar-spinal-stenosis-lss":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100594965","is-it-really-necessary-going-all-over-the-top-in-patients-with-symptomatic-lumbar-spinal-stenosis-100594965",false,"NCT07026305","Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?","Non-inferiority of Osseous Decompression of the Lumbar Canal Until Normalization of Epidural Pressure Compared to Conventional Open Laminectomy in Patients With Symptomatic Lumbar Spinal Stenosis.","Inclusion Criteria:\n\n* Surgical indication determined by:\n\n  * Lower back pain and\u002For lower extremity pain for more than 3 months.\n  * Pain refractory to conservative medical management (analgesics, physical therapy, epidural block).\n  * Clinical criterion of neurogenic claudication defined as a score ≥11 on the N-CLASS scale.\n  * Preoperative magnetic resonance imaging (MRI) showing lumbar canal stenosis.\n* Patient consents to the proposed surgical intervention.\n* Patient agrees to participate in the study by signing the informed consent form.\n\nExclusion Criteria:\n\n* Foraminal or lateral recess stenosis.\n* Symptomatic disc herniation at the segment to be treated.\n* Spondylolisthesis \\> Grade I (Meyerding) (translation \\>25% of the vertebra) or spondylolysis.\n* Radiological instability defined as \\>5 mm of anteroposterior translation on dynamic flexion-extension spine X-rays.\n* Scoliosis with Cobb angle \\>30°.\n* Compression fracture at the level to be treated.\n* Prior surgery at the same segment to be treated.\n* Prior infection at the segment to be treated.\n* Contraindication for MRI.\n* Diagnosis of major depressive disorder or dysthymia according to DSM-V criteria.","ALL","50 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to evaluate the theory of epidural pressure by comparing a surgical procedure that aims to perform less bone resection compared to conventional surgery in patients with lumbar spinal stenosis.\n\nThe main questions it aims to answer is:\n\nIs bony decompression of the lumbar canal performed until normalization of epidural pressure not inferior to conventional surgery in achieving clinical improvement in patients with symptomatic lumbar canal stenosis?\n\nResearchers will:\n\nCompare conventional open laminectomy to bony decompression of the lumbar canal until normalization of epidural pressure is achieved.\n\nParticipants will:\n\n* Be randomized to one of the two surgical interventions: laminectomy guided by epidural pressure measure or conventional laminectomy.\n* Visit the clinic for checkups and tests until 1 year of follow-up.",[26,27,28],"Lumbar Canal Stenosis","Lumbar Spinal Stenosis","Lumbar Spinal Stenosis (LSS)",[30,31,32,33],"lumbar canal stenosis","spinal epidural pressure","lumbar spinal stenosis","LSS","RECRUITING","2025-06-18",{"date":37,"type":38},"2025-06-24","ACTUAL",{"date":40,"type":38},"2025-04-21",{"date":42,"type":20},"2026-10",{"name":44,"class":45},"Universidad Complutense de Madrid","OTHER"]